Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals
Reexamination Certificate
1999-06-18
2002-06-11
Chin, Christopher L. (Department: 1641)
Chemistry: analytical and immunological testing
Involving an insoluble carrier for immobilizing immunochemicals
C436S523000, C436S805000, C436S809000, C435S287200, C435S287300, C435S288600, C422S051000, C422S067000, C422S063000, C422S070000, C422S072000, C210S198100, C210S198200, C210S263000, C210S268000
Reexamination Certificate
active
06403384
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a device for separating a fluid component, such as plasma, from a biologic sample, such as blood, using microspheres and analyte specific labeling. This invention also relates to a device and method for quantitative determination of an amount of analyte present in biologic fluids. The invention further relates to a quantitative. assay method and device for measuring one or more analytes in a biologic fluid sample using a point-of-care assay method and device. The test results can be analyzed using a suitable analyzer and, optionally, the assay test results are transmitted by way of digital transmission systems to permit further evaluation of the data.
BACKGROUND OF THE INVENTION
There are presently many examples of one step assays for measuring analytes in fluid. A common assay is the pregnancy test device which involves contacting a urine sample with a test pad, which urine moves by capillary flow along the bibulous chromatography strips whereby the presence of human chorionic gonadotropin (HCG) will be detected usually as shown by a coloured line because of the reaction between HCG and reagents in the bibulous chromatography strips. This is an example of a chromatographic assay.
U.S. Pat. No. 5,766,961 issued Jun. 16, 1998 and U.S. Pat. No. 5,770,460 issued Jun. 23, 1998 are both entitled “One-Step Lateral Flow Nonbibulous Assay”. “Nonbibulous lateral flow” refers to liquid flow in which all of the dissolved or dispersed components of a liquid, which are not permanently entrapped or filtered out, are carried at substantially equal rates and with relatively unimpaired flow laterally through a stabilized membrane. This is distinguished from preferential retention of one or more components as would occur, for example, in materials capable of absorbing or imbibing one or more components, as occurs in chromatographic configurations. In this one-step assay, a sample (which may contain the analyte of interest) is collected on the “sample receiving zone” from which it flows to the “labelling zone” at which point it encounters a specific binding reagent for the analyte coupled to visible moieties (the “assay label”), then flows to a “capture zone” where the analyte bound to visible moieties is captured.
In U.S. Pat. No. 5,540,888 issued Jul. 30, 1996 and entitled “Liquid Transfer Assay Devices”, the invention described is a device for biochemical diagnostic assays. It comprises two liquid flow channels of porous material which transfer liquid by capillary flow to a common site following simultaneous application of the liquid to the ends of the channels. The channels interconnect at a certain point and then both continue in an arrangement analogous to an electrical bridge circuit. By selecting the hydraulic resistances of the arms of this circuit, the flow can be controlled across the bridge.
U.S. Pat. No. 5,300,779 issued Apr. 5, 1994 entitled “Capillary Flow Device” describes methods and devices for measuring an analyte in a sample mixed with reagents, the devices defining a flow path. The specific binding by agglutination may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering which permit measurement of the analyte of interest.
In U.S. Pat. No. 5,110,724 issued May 5, 1992, entitled “Multi-Analyte Device”, the invention described is an assay device for assaying multiple analytes in a drop-sized blood sample. A dispenser distributes a small volume blood sample to multiple transfer sites by capillary flow of the blood sample through sieving and distributing matrices which separate blood cells from plasma as the sample fluid migrates toward the transfer sites. A test plate in the device carries multiple absorbent pads, each containing reagent components for use in detection of a selected analyte. The test plate is mounted on the dispenser toward and away from a transfer position at which the exposed surface regions of the pads are in contact with associated sample-transfer sites, for simultaneous transfer of sample fluid from such sites to the pads in the support.
In U.S. Pat. No. 5,039,617 entitled “Capillary Flow Device and Method for Measuring Activated Partial Thromboplastin Time”, the invention described measures “activated partial thromboplastin time” (APTT) on a whole blood sample by applying the sample to a capillary tract with reagents capable of initiating an APTT analysis, wherein clotting time is measured by the cessation of blood flow in the capillary tract. This is an example of a risk evaluation based on coagulation.
In U.S. Pat. No. 4,753,776 entitled “Blood Separation Device Comprising a Filter and a Capillary Flow Pathway Exiting the Filter”, the invention describes a method for separating plasma from red blood cells. The driving force for the movement of plasma from the filter to the reaction area of a device utilizing the method is capillary force provided by a tubular capillary. A filter is selected from glass microfiber filters of specified characteristics.
The U.S. Pat. No. 5,135,719 issued Aug. 4, 1992, entitled “Blood Separation Device Comprising a Filter and Capillary Flow Pathway Exiting the Filter”, the similar invention is described and the glass fibre filters are prepared from fibers with diameters between 0.10 and 7.0 &mgr;m.
In U.S. Pat. No. 4,447,546 issued May 8, 1984, entitled “Fluorescent Immunoassay Employing Optical Fibre in Capillary Tube”, a short length of precise diameter capillary tubing with an axially disposed optical fibre to which is immobilized a monolayer of a component of the antibody antigen complex (eg. an antibody) is described. The tubing is immersed in the sample.
U.S. Pat. No. 5,610,077 issued Mar. 11, 1997, entitled “Processes and Apparatus for Carrying Out Specific Binding Assays”, describes the well known antibody binding to antigen assay. The sample which may contain the analyte (a), (the substance being tested for) is mixed with (b) an antibody which binds to the substance being tested for, which antibody is immobilized on a solid support, and (c) another antibody for the substance being tested for which is conjugated to a detectable marker, to thereby form a complex between (b), the substance being tested for and (c) and causes the marker to be immobilized and detected.
In U.S. Pat. No. 4,943,522 issued Jul. 24, 1990, entitled “Lateral Flow, Non-Bibulous Membrane Assay Protocols”, the described invention is a method and apparatus for conducting specific binding pair assays, such as immunoassays, the test substrate is a porous membrane on which a member of the binding pair is affixed in an “indicator zone”. The sample is applied and is permitted to flow laterally through the indicator zone and any analyte in the sample is complexed with the affixed specific binding member, and detected. A novel method of detection employs entrapment of observable particle in the complex, for instance, red blood cells of blood can be used as the observable particles for detection of the complex.
An example of a method to separate red blood cells from whole blood samples is found in U.S. Pat. No. 5,118,428 issued Jun. 2, 1992, entitled “Method to Remove Red Blood Cells from Whole Blood Samples”. In the described invention, red blood cells are removed from whole blood samples with a solution containing an acid. The agglutinated red blood cells are then removed from the resulting suspension by procedures of filtration, centrifugation or decantation, leaving an essentially red blood cell-free serum or plasma sample.
In U.S. Pat. No. 5,073,484, entitled “Quantitative Analysis Apparatus and Method”, an analyte is measured along a liquid flow path which includes a number of reaction-containing reaction zones spaced apart along the flow path. Detector means are employed to detect analyte, reactant or predetermined product in the reaction zones, the number of zones in which detection occurs indicating the amount of analyte in the liquid.
In U.S. Pat. No. 5,536,470 issued Jul. 16, 1986, entitled “Test Carrier for Determining an Analyte in Whole Blood”
Lyon & Lyon LLP
Padmanabhan Kartic
Umedik, Inc.
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